MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	ESX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused fibrillation.The patient did not report receiving any medical intervention.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a cpap device's sound abatement foam became degraded and caused atrial fibrillation.The patient did not report receiving any medical intervention.The device was returned to an authorized service center for evaluation.The device was visually inspected.The service center found no evidence of contamination.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The device passed all final testing.There was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12787471
• Report Number: 2518422-2021-06562
• Device Sequence Number: 4005158
• Product Code: BZD
• UDI-Device Identifier: 00606959024274
• UDI-Public: 00606959024274
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ESX500S15
• Device Catalogue Number: ESX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown